Cook Incorporated: Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914

Hazard

Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

Details from the source

Reason for recall: Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. Distribution: Domestic distribution nationwide. Foreign distribution worldwide. Quantity: 202 US; 11 OUS Lot/code info: RFPC-35-145 G07914 UDI-DI: 00827002079144 Lots/Expiration Date: 14828624 06-07-2025 14828638 06-07-2025 14837046 12-07-2025 NS14828650 06-07-2025

UPC codes

00827002079144

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.